NCT04269551已完成1 期
A Multicenter, Phase 1b, Open Label, Nonrandomized, Single Dose Study Evaluating the Safety, Tolerability and Activity of BIVV020 in Adults With Cold Agglutinin Disease
Bioverativ, a Sanofi company10 个研究点 分布在 6 个国家目标入组 12 人开始时间: 2020年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 10
- 主要终点
- Assessment of adverse events (AEs)
研究概览
简要总结
Primary Objective:
To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020
Secondary Objectives:
To assess, in participants with cold agglutinin disease, after a single dose of intravenous (IV) BIVV020:
- The effect of BIVV020 on complement mediated hemolysis
- The pharmacodynamics (PD) of BIVV020 relating to complement inhibition
- The pharmacokinetics (PK) of BIVV020
- The immunogenicity of BIVV020
详细描述
Up to 23 weeks (screening period up to 8 weeks, treatment period 15 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIVV020 IV
Experimental
Single administration dose 1, plus two optional doses of BIVV020 administered intravenously.
干预措施: BIVV020 (Drug)
结局指标
主要结局
Assessment of adverse events (AEs)
时间窗: Screening to Day 106
Number of participants with adverse events (AEs)
次要结局
- Complement System Classical Pathway Levels as Measured by WIESLAB Assay(Day 1 to Day 106)
- Complement System Alternative Pathway Levels as Measured by WIESLAB Assay(Day 1 to Day 106)
- Total Complement (CH50) Levels(Day 1 to Day 106)
- PK parameter: Cmax(Day 1 to Day 106)
- Mean change from baseline in hemoglobin over time(Day 1 to Day 106)
- Total Complement Factor C4 Levels(Day 1 to Day 106)
- PK parameter: tmax(Day 1 to Day 106)
- Mean change from baseline in bilirubin over time(Day 1 to Day 106)
- PK parameter: AUClast(Day 1 to Day 106)
- PK parameter: AUC0-∞(Day 1 to Day 106)
- Number of participants with anti-BIVV antibodies(Day 1 to Day 106)
研究者
研究点 (10)
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